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Report Reviewer
Syneos HealthClinical Solutions team member executing Central Report Review activities with a focus on patient safety and compliance. Collaborating with teams to ensure protocol adherence and data integrity.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical monitoring and compliance, focusing on patient safety, protocol adherence, and data integrity. Proficient in developing annotated visit reports and documenting observations for effective communication and action planning.
Highest-signal resume keywords
Clinical MonitoringAnnotated Visit Report DevelopmentProtocol ComplianceData Integrity AssessmentCTMS Documentation
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Central Report ReviewSite Monitoring Documentation ReviewProtocol Deviation ReportingRisk AssessmentObservation Documentation
Soft Skills
Effective CommunicationProblem-SolvingCollaboration
Tools & Technologies
CTMS
Industry Keywords
GCP CompliancePatient SafetyClinical Trial ManagementOperational PerformanceClinical Training
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Responsible for execution of Central Report Review activities on the study
- May support development of annotated visit reports
- Reviews the content and quality of site and central monitoring documentation
- Ensure deliverables are provided according to company and/or sponsor specifications
- Documents observations noted during reviews and ensures protocol deviations or action items are reported as necessary
Requirements
What you’ll need- Monitoring strategy defined, with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity
- Development of annotated visit reports such as PSV, SIV, IMV, COV & SCAN
- Reviews the content and quality of site and central monitoring documentation
- Document requested revisions and approvals in CTMS
- Assess factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site
- Immediately communicates/escalates serious issues to Clinical Trial Manager/Project Manager
- Documents observations noted during reviews
- May assesses CRA/CM report quality, risks, and trends as well as operational performance and summarizes the findings for CTM review and action planning
- Participates in clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements
Benefits
Comp & perks- We are passionate about developing our people, through career development and progression
- supportive and engaged line management
- technical and therapeutic area training
- peer recognition and total rewards program
- We are committed to building an inclusive culture – where you can authentically be yourself